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The goal of this clinical trial is to find out whether the functional food Benemix® helps treat constipation in adults and whether it is safe to use.
The main questions this study aims to answer are:
Does Benemix® help improve bowel movement frequency and consistency in adults with constipation?
What medical problems, if any, do participants experience while taking Benemix®?
Adults with constipation will take Benemix® every day for 15 days. During the second week, participants will have either an in-person clinic visit or a telemedicine appointment for checkups and tests.
Participants will also receive follow-up phone calls to record:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benemix Functional Food Group | Experimental | Participants in this arm will receive Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder, administered orally once daily for 15 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder | Dietary Supplement | Benemix® is a functional food formulation designed to support intestinal health and relieve functional constipation in adults. It contains a combination of turmeric (Curcuma longa), onion (Allium cepa), magnesium, and lactose-free skimmed milk powder. Participants will consume one oral serving of Benemix® once daily for 15 consecutive days. The product is provided as a powdered formulation that must be reconstituted in water or milk prior to consumption. Benemix® differs from other dietary interventions by combining bioactive compounds from turmeric and onion, which have anti-inflammatory and digestive properties, with magnesium, known for its osmotic laxative effect. The lactose-free dairy base is intended to improve tolerability in individuals who are sensitive to lactose. All participants will receive instructions on proper preparation and use of the product. Treatment adherence will be monitored through follow-up phone calls and daily symptom diaries. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of bowel movements | Number of spontaneous bowel movements per week recorded using a daily patient diary. Unit of Measure: Number of bowel movements per week | From baseline (Day 0) to Day 15. |
| Change in stool consistency measured by the Bristol Stool Form Scale (BSFS) | Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS), a validated 7-point scale (Type 1 = separate hard lumps; Type 7 = entirely liquid). Types 3-4 represent normal stool consistency. Lower scores indicate harder stools; higher scores indicate looser stools. | From baseline (Day 0) to Day 15. |
| Incidence of adverse events | Number and type of adverse events recorded during the 15-day intervention period, classified according to severity and relationship to the product. Number of participants with adverse events | Throughout the 15-day intervention period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javier M Ceballos Rueda, PhD | Contact | +573174268448 | javier.ceballos@udea.edu.co |
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| ID | Term |
|---|---|
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| D008670 |
| Metals |